BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE-LINK

    MDR report key: 25037717 · Received April 29, 2026

    Report

    Report Number
    1416980-2026-01498
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Report Date
    April 29, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412475387
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3 EVENT DATE / D10 THERAPY DATE: MARCH 2026. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NON-DEHP STANDARD BORE CATHETER EXTENSION SET LEAKED AT THE CONNECTION SITE. AN EMERGENCY DEPARTMENT REGISTERED NURSE STARTED AN IV ON THE PATIENT AND A "J LOOP" (EXTENSION SET) WAS CONNECTED CORRECTLY AND TIGHTENED; HOWEVER, BLOOD LEAKED FROM THE CONNECTION ONTO THE PATIENT AND BED. WHEN THE NURSE ATTEMPTED TO FLUSH THE IV, FLUID CONTINUED TO DRIP FROM THE CONNECTION SITE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094307 ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 7N8301 R26A04086 00085412475387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown